Veeva Systems Inc. · NYSE:VEEV
Veeva Systems — 20R2 Customer Webinar (July 2020)
48 slides from Veeva Systems's conference presentation, Jul 23, 2020
Slide 1: 20R2 Customer Webinar: Studio & Admin
20R2 Customer Webinar Studio & Admin July 23, 2020 Revisions - July 28, 2020
Slide 2: Revisions
Revisions to the Deck 0n 07/28/20: • Casebook Variables Feature changed from Revisions • “New Studies Only” to “Existing studies” Rules Configurator Feature changed from 07/28/20 “New Studies Only” to “Existing studies” • Restricted Data Permission - typo change from Data Manager to Deployment Admin
Slide 3: Sharon Lin and Cory Etzcorn
Sharon Lin Principal Product Manager, Veeva CDMS Cory Etzcorn Product Manager, Veeva CDMS
Slide 4: CDMS Product Team
CDMS Product Team Dennis Kochanski Mohammed Al-Adeeb Senior Product Manager, Senior Product Manager, Vault CDMS Vault CDMS Quentin Paresys Rakesh Monassery Product Manager, Senior Product Manager, Vault CDMS Vault CDMS Copyright © Veeva Systems 2020 4
Slide 5: Important Disclosures
Important Disclosures The following is intended to outline Veeva’s general product direction. It is intended for informational purposes only and does not form part of any contract. It is not a commitment to deliver any specific functionality and it should not be relied upon in making purchasing deci
Slide 6: Interact With Us!
Interact With Us! Copyright © Veeva Systems 2020 6
Slide 7: October 13–14, 2020 industry event
October 13–14, 2020 Develop new industry partnerships Share best practices Network with sponsors, CROs, & sites CLINICAL QUALITY & MANUFACTURING REGULATORY SAFETY IT Copyright © Veeva Systems 7 2020
Slide 8: Veeva Vault Release Schedule
Veeva Vault Release Schedule 20R3 Jan Feb Dec Nov Mar 2020 Oct CDMS Product Apr 20R1 Release Sep Strategy May Aug Jun Jul 20R2 Copyright © Veeva Systems 2020 8
Slide 9: 20R2 Release Calendar
20R2 Release Calendar Sun Mon Tue Wed Thu Fri Sat 19 20 21 22 23 24 25 JUL 20R2 Release webinar 9 AM PT - All Customers 10 AM PT - Studio & Admin 26 27 28 29 30 31 1 2 3 4 5 6 7 8 Validation Docs 20R2 Pre - Release 9 10 11 12 13 14 15 AUG 16 17 18 19 20 21 22 20R2 General Release Customer Copyright
Slide 10: Pre-Release Environment
Pre-Release Environment https://login.veevavault.com AUG ● Clone of UAT ○ Special Request for Dev Monday ● Users ○ Contact Veeva Post 3rd Implementation Manager to add users ● Available up to 4 weeks after the 20R2 upgrade Copyright © Veeva Systems 2020 10
Slide 11: Validation Documents
Validation Documents On Monday, Aug 3 ● Validation Project Plan AUG ● IOQ Protocol ● Business Requirements Monday Documents ● Validation Impact Assessment 3rd On Monday, Aug 10 ● Traceability Matrix ● System Release Memo ● Executed OQ Scripts (unexecuted in Word format available upon request) Copyri
Slide 12: 20R2 Go Live
20R2 Go Live • ALL customer vaults upgraded to 20R2 AUG • EU starts at 2:00pm PT Friday • APAC & US starts at 5:00 PM PT • May take up to 6 hours 21st Copyright © Veeva Systems 2020 12
Slide 13: 20R2 General Release Resources
20R2 General Release Resources • Resources Available • https://cdmshelp.veeva.com/lr/rn/general-releases/20r2/ − Important Dates − Notifications Opt-In − Feature information − Pre- Release Information − Release Information − Release Impact Assessment (RIA) Copyright © Veeva Systems 2020 13
Slide 14: 20R2 Feature Summary
20R2 Feature Summary Sites Study Designer Admin Coding ● Restricted Data ● Delete Subject & Reset ● Cascading Form Deletion ● Dynamic Review Plans ● Upversioning Impact Event ● Form Copy Enhancements by Subject Status or Report ● Study Closeout ● Copy Codelists and Units Percentage ● Group Coding ●
Slide 15: Feature Enablement Detail
Feature Enablement Detail Auto-On Features Configurable Features Visible •Sites •CRAs •Data Managers •Clinical Assessments •Coders Auto-On Configuration Support •Coder Admin •Admins Turned On Day 1 Turned Off Turned Off •Study Designers Automatically Requires Requires •Report Users available Configu
Slide 16: Studio (Study Designer)
V Studio (Study Designer)
Slide 17: Cascading Form Deletion
Cascading Form Deletion Automatic • Overview During form deletion, there is an option to “include all related objects” and delete any related objects associated to that form. But if that related object is associated to another object it will not be deleted. This is useful when you have copied a form
Slide 18: Form Copy Enhancements
Form Copy Enhancements Automatic • Overview The default setting when copying form is now to “use existing” Coding configuration is now copied. And there is a coding validation check, to see if the verbatim and related item is still available. • Business Value Reduces development time for new studies
Slide 19: Copy Codelists and Units
Copy Codelists and Units Automatic • Overview Ability to copy Codelists and Units • Business Value Decreases study development time for new studies. Provides a better facility for standardization. Visible VISIBLE TO ALL STUDY DESIGNERS Copyright © Veeva Systems 2020 19
Slide 20: Validation Script for Rule Changes
Validation Script for Rule Changes Automatic • Overview Users can now create a validation script that documents rules that have changed between study environments. When you run the single casebook comparison, and select “Create a Validation Test Script”. A Validation Script spreadsheet will be creat
Slide 21: Template Vaults
Template Vaults Automatic • Overview While provisioning a Vault, you can identify a Template Vault that houses all your standards so you can copy those standards into any Vault. This provides an easy method to create a new study from a vault where standards are managed. Template vaults will never be
Slide 22: Relaxed Study Update Restrictions
Relaxed Study Update Restrictions Automatic • Overview Users can now change non-repeating to repeating (on Event Group, Form, and Item Group) and Non-dynamic to Dynamic (Event and Form). • Business Value Provides better support for post-go-live changes, putting more control in the hands of the study
Slide 23: System Design Specs (SDS) Enhancements
System Design Specs (SDS) Enhancements Automatic • Overview SDS now includes: − New formatting − A Review Tab for Review Plans − An Assessments Tab for Assessments − Better documentation about Dynamic creation of Event Groups, and disabled rules − Layout Information (like Item Group - Header Visible
Slide 24: Restricted data configuration
Restricted data configuration Automatic • Overview For studies created after 20R2 using Data Model version 2, a new checkbox will be available at the Form Properties panel that will mark a Form as Restricted. This setting is at the Form level, meaning that it will apply to all uses of that Form acro
Slide 25: Study Closeout Signature Definition
Study Closeout Signature Definition Automatic • Overview Study Closeout Signature Definition is used to assign the language to be associated when the electronic signature occurs for the closeout PDFs. Only one Study Closeout signature can exist for each study. Signature can be edited, but not be del
Slide 26: Studio Demo
DEMO Studio Demo Copyright © Veeva Systems 2020 26
Slide 27: Rules
Rules
Slide 28: Query future dates for events
Query future dates for events Automatic • Overview A new setting was added on Events to indicate if a query needs to be automatically fired if an event date is entered in the future. This setting is at the Event level, meaning that it will apply to all uses of that Event across the schedule. • Busin
Slide 29: Query on event date out of range
Query on event date out of range Automatic • Overview Studio now allows Study Designers to define if a query needs to be opened when an event date is entered out of the planned range. A new study setting option was added to allow setting this parameter at a study level, meaning that all event dates
Slide 30: Rule Navigation Layout
Rule Navigation Layout Automatic • Overview The Rules tab is now split into 3 tabs in a specific Rules section. • Casebook Variables • Comparison Rules • Custom Rules • Business Value It separated the distinct Rules for easier navigation Visible Studies on Data Model v2 (post 20R2) Copyright © Veeva
Slide 31: Data Driven Review Plan Assignment
Data Driven Review Plan Assignment Automatic • Overview Review Plan can be assigned based on data entered using a rule, which can than override an already assigned plan. Prior to 20R2, only one review plan could be assigned for each form, meaning that items would have the same review mode (required,
Slide 32: Casebook variables
Casebook variables Automatic • Overview Casebook Variables provide a quick way of identifying key items in the schedule that are common in most studies and used as a reference point. For example birthdate or Informed Consent Date. The new Casebook Variables are static, and cannot be modified. 9 Case
Slide 33: Rule Configurator (Comparison Rules)
Rule Configurator (Comparison Rules) Automatic • Overview The Rule Configurator allows quick simple comparisons between dates OR between datetimes. Comparison Rules are limited to date and datetime comparisons. There is an expandable grid view of the schedule showing all date or datetime items. Item
Slide 34: Sequence number in expressions
Sequence number in expressions Automatic • Overview A sequence number can be specified in identifiers for repeating event groups, forms and item groups E.g. $CYCLE[3].DAY8.LBCHEM.LB[5].RESULT For example, compare the visit dates between cycle 1 and cycle 2 or compare values between second and third
Slide 35: Admin
V Admin
Slide 36: Study Closeout
Study Closeout Automatic • Overview Sponsors can generate Closeout PDFs at the end of a study from EDC Tools when locking a site(s). Once ready, the Closeout PDFs can be made available to site users for download and acceptance. The system supports automated and manual email notifications to remind s
Slide 37: Study Closeout Process
Study Closeout Process Job Is queued 1 Assign user 2 Define Study 3 Lock Study. 4 Notify Site 5 Site receives permission Closeout Generate that PDFs are Email for Closeout Signature Closeout PDFS. available notification PDFs have been 6 Site downloaded and Downloads accepted by Site. the PDFs 7 Site
Slide 38: Dynamic Review Plans by Status or Percentage
Dynamic Review Plans by Status or Percentage Automatic • Overview Plans can be defined by Study Country, Study Site, Subject Status, or a minimum percentage of subjects for assignment. A combination of all the above can occur to help customize your Review plan. For example for subjects that have a S
Slide 39: Minimum Coverage Percentage (MCP)
Minimum Coverage Percentage (MCP) Casebooks MCP Site 101 – Plan A, at least 30% 1 0% Plan A 2 50.00% 3 33.33% 4 25.00% Plan A 5 40.00% 6 33.33% 7 28.57% Plan A 8 37.50% 9 33.33% 10 30.00% 11 27.27% Plan A 12 33.33% 13 30.77% Copyright © Veeva Systems 2020 39
Slide 40: Version 1 vs Version 2
Version 1 vs Version 2 New Studies Version 1 Version 2 Minimum Coverage Percentage Assignment by Subject Status Assignment by Subject Ordinal Manual Assignment Assignment by Country (all Sites within the country) Cannot migrate a Study from version 1 to version 2. Copyright © Veeva Systems 2020 40
Slide 41: System Tools
System Tools Automatic • Overview − New subtab under Tools called “System Tools” − Role Management is now under the System Tools − Change Reasons - Define the Drop down list for each object (Intentionally Left Blank, Reset, Did not occur…) − Deployment - Vault level deployments − Custom Objects - De
Slide 42: Vault Deployments
Vault Deployments Automatic • Overview Users can deploy vault-level configuration from your development or sandbox vault to UAT and Production. This includes Custom Roles, Change Reasons, Custom Objects, Reports, and Dashboards. This is in addition to the existing deployment of the Study environment
Slide 43: Vault Difference Report
Vault Difference Report Automatic • Overview Users can run a report to show the differences between two vaults, which is similar to the Study Diff Report but at the Vault level. The report includes any changes to configuration of custom Study Roles, Custom Vault Objects, Reports, Dashboards, and Use
Slide 44: Delete Site (non-Production environment)
Delete Site (non-Production environment) Automatic • Overview In non-production environments, users will have the ability to delete Sites that are no longer required in a Study. • Business Value Removing unwanted Sites makes the study easier to manage. Visible ADMIN Copyright © Veeva Systems 2020 44
Slide 45: Study Role Enhancements
Study Role Enhancements Automatic • Overview − For 20R2, User Defined (aka Custom) role with “Manage Review Plan Assignment” permission will automatically be granted access to execute Jobs. − Any Study Role (Standard or User Defined) that contains the below permission will be granted Access to All S
Slide 46: Study Role Enhancements (contd.)
Study Role Enhancements (contd.) Automatic • Overview − The CDMS Study Designer standard role now has the following permissions: • Manage Review Plan Assignment • View Form Linking & Edit Form Linking • View Study Design • Manage Email Group Assignment − The CDMS User Administrator now has “Manage S
Slide 47: CDMS 20R2 API
CDMS 20R2 API Automatic • Overview CDMS API (Application Programming Interface) allows users to interact with and retrieve data from the CDMS application. • Business Value Provide IRTs the ability to Retrieve study data. • List • Get Event Data API • Get Form Data API • API Documentation • https://d
Slide 48: Thank you!
V Thank you!